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Hiring Patient Safety Associate I
Parexel
Mohali / Hyderabad / Bengaluru
Freshers
Pharmacovigilance
Drug Safety
🏢 About Parexel
Parexel is a globally recognized Contract Research Organization (CRO) specializing in clinical development, regulatory consulting, and pharmacovigilance services. The company supports pharmaceutical and biotechnology organizations worldwide in bringing life-saving therapies to market.
With strong global presence and structured learning programs, Parexel provides excellent career opportunities in clinical research and drug safety.
📌 Job Overview
- Role: Patient Safety Associate I
- Company: Parexel
- Location: Mohali / Hyderabad / Bengaluru
- Experience: Freshers
- Department: Pharmacovigilance / Drug Safety
- Job Type: Full-Time
🔬 Key Responsibilities
ICSR Processing & Case Management:
- Monitor incoming safety reports (literature, databases, emails)
- Perform data entry in safety databases
- MedDRA coding of adverse events
- Assess seriousness, causality, and expectedness
- Write detailed case narratives
- Handle query management and follow-ups
Safety Reporting & Regulatory Submissions:
- Submit ICSRs to regulatory authorities
- Support PBRER / DSUR safety reports
- Maintain compliance with global timelines
- Assist in regulatory documentation and submissions
Literature & Signal Detection:
- Conduct literature screening and ADR identification
- Support signal detection activities
- Maintain safety databases and updates
🎓 Eligibility Criteria
- B.Pharm / M.Pharm / Pharm.D
- BSc / MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry)
- MSc Pharmacovigilance / Clinical Research
Required Skills:
- Basic pharmacovigilance knowledge
- Understanding of ICH guidelines
- Knowledge of MedDRA coding (preferred)
- MS Office proficiency
- Strong attention to detail
- Interest in drug safety & regulatory processes
⭐ Salary & Benefits
- ₹3.5 – ₹5.5 LPA (Estimated)
- Structured pharmacovigilance training
- Exposure to global clinical trials
- Career growth in drug safety & regulatory roles
- Opportunity to work with international teams
🚀 Career Growth
- Drug Safety Associate
- Pharmacovigilance Specialist
- Safety Scientist
- Regulatory Affairs Roles
🎯 Interview Preparation Tips
- Revise ICSR workflow & case processing
- Understand MedDRA hierarchy
- Learn SAE vs AE concepts
- Study basic ICH-GCP & PV guidelines
- Practice case narrative writing
Helpful resources:
📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Ensure your pharmacovigilance basics are clear.
Kindly read the entire job description carefully before applying. Ensure your pharmacovigilance basics are clear.
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